Systems and methods for affecting the biomechanical properties of connective tissue

ABSTRACT

A device for delivering ablative medical treatments to improve biomechanics comprising a laser for generating a beam of laser radiation used in ablative medical treatments to improve biomechanics, a housing, a controller within the housing, in communication with the laser and operable to control dosimetry of the beam of laser radiation in application to a target material, a lens operable to focus the beam of laser radiation onto a target material, and a power source operable to provide power to the laser and controller.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Appl. No. 61/798,379, filedMar. 15, 2013, and is related to the following U.S. Appl. Nos.: U.S.Appl. No. 60/662,026, filed Mar. 15, 2005; U.S. application Ser. No.11/376,969, filed Mar. 15, 2006; U.S. Appl. No. 60/842,270, filed Sep.5, 2006; U.S. Appl. No. 60/865,314, filed Nov. 10, 2006; U.S. Appl. No.60/857,821, filed Nov. 10, 2006; U.S. application Ser. No. 11/850,407,filed Sep. 5, 2007; U.S. application Ser. No. 11/938,489, filed Nov. 12,2007; U.S. application Ser. No. 12/958,037, filed Dec. 1, 2010; and U.S.application Ser. No. 13/342,441, filed Jan. 3, 2012, the entire contentsand disclosures of which are hereby incorporated by reference.

FIELD

The subject matter described herein relates generally to systems andmethods for affecting the biomechanical properties of connective tissueand more specifically, to systems and methods for treating connectivetissue to alter the fundamental and biomechanical properties of theconnective tissue.

BACKGROUND

Connective tissue is tissue that supports and connects other tissues andparts of the body. The fundamental and biomechanical properties ofconnective tissue, such as scleral tissue of the eye, may change as itages. These fundamental and biomechanical tissues have properties whichinclude, but are not limited to, their structure, function, immunology,elasticity, shock absorption, resilience, mechanical dampening,pliability, stiffness, rigidity, configuration, alignment, deformation,mobility, volume, biochemistry and molecular genetics of connectivetissue proper and newly metabolized connective tissue. The alterationsof these properties may result in an accumulation of low gradestress/strain of the connective tissue. This can occur by acute injuryor as a normal gradual process of aging. The alterations of theseproperties of connective tissue may change the overall desiredproperties of the connective tissue and may also undesirably affect thesurrounding tissues, structures, organs, or systems related to theconnective tissue. Examples of such undesirable affects are increasedtension, loss of flexibility, contracture, fibrosis, or sclerosis, anyof which can prevent the connective tissue or structures that arerelated to the connective tissue from performing their desired function.

Natural alterations in fundamental and biomechanical properties,specifically pliability and elasticity of the scleral tissue of the eyemay affect the ability of the eye to focus. These alterations may becaused by disease or age-related changes to the tissue. Thesealterations of the scleral tissue may also contribute to an increase inintraocular pressure and to the loss of the contrast sensitivity of theeye or visual field of the eye. Biomechanical and structural alterationsof the sclera may affect the refractive ability as well as theefficiency of the homeostatic functions of the eye such as intraocularpressure, aqueous production, pH, balance, vascular dynamics, metabolismand eye organ function. Furthermore, alterations of the scleral tissuemay contribute to damage to the mechanoreceptors, photoreceptors, orsensory receptors in tissue layers and structures that are directly orindirectly related to the scleral tissue. Additionally, fundamental andbiomechanical alterations of the scleral tissue may also be acontributing factor in the ability of the cerebral cortex to processaccurate visual stimulus necessary for processing visual signals intoaccurate visual perception.

Presbyopia is a condition which affects focusing ability of the eye,especially in the elderly. Presbyopia is the loss of accommodation—theability to focus through a range of near to far object. Some causes ofpresbyopia are considered to be a loss of elasticity in the crystallinelens and loss of strength in the ciliary muscles of the eye. Althoughnaturally occurring, presbyopia affects a person's vision includingincreased eyestrain, visibility issues in low or dim lighting, andfocusing problems on small objects. As such, presbyopia causes a loss ofaccommodation.

It is therefore desirable to provide improved systems and methods foraltering the biomechanical properties of connective tissue havingadvantages not heretofore taught.

SUMMARY OF THE INVENTION

Systems and methods for altering the biomechanical properties ofconnective tissue are described herein that overcomes the limitationsnoted above.

In general a device for delivering medical treatments is disclosed whichcomprises a laser for generating a beam of laser radiation, a housing, acontroller within the housing, in communication with the laser andoperable to control the qualities of the beam of laser radiation inapplication to a target material, a lens operable to focus the beam oflaser radiation onto a target material, and a power source operable toprovide power to the laser and controller.

Other features and advantages of the present invention will becomeapparent from the following more detailed description, taken inconjunction with the accompanying drawings, which illustrate, by way ofexample, the principles of the presently described invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Illustrated in the accompanying drawing(s) is at least one of the bestmode embodiments of the present invention. In such drawing(s):

FIG. 1 illustrates an overview of a medical treatment system using alaser according to an embodiment of the present invention;

FIG. 2 illustrates a laser treatment system according to an embodimentof the present invention;

FIG. 3 illustrates a laser treatment system according to an embodimentof the present invention;

FIG. 3A illustrates a laser treatment system according to an embodimentof the present invention;

FIG. 3B illustrates a laser treatment system according to an embodimentof the present invention;

FIG. 3C illustrates a camera correction system according to anembodiment of the present invention;

FIG. 3D illustrates a flow diagram of a camera-based eye tracker processaccording to an embodiment of the present invention;

FIG. 3E illustrates a flow diagram for a laser ablation procedureaccording to an embodiment of the present invention;

FIG. 4 illustrates a laser treatment system according to an embodimentof the present invention;

FIG. 4A illustrates a laser treatment system including ablation poredepth according to an embodiment of the present invention;

FIG. 4B illustrates a flow diagram of OCT-based depth control accordingto an embodiment of the present invention;

FIG. 5A illustrates a laser treatment system lens placement according toan embodiment of the present invention;

FIG. 5B illustrates a laser treatment system lens placement according toan embodiment of the present invention;

FIG. 5C illustrates a laser treatment system lens placement according toan embodiment of the present invention;

FIG. 6 illustrates a laser treatment system component map showingrelation of related subsystems according to an embodiment of the presentinvention;

FIG. 7 illustrates a laser treatment system according to an embodimentof the present invention;

FIG. 8 illustrates an eye treatment map according to an embodiment ofthe present invention;

FIG. 9 illustrates a front view of an pore matrix according to anembodiment of the present invention;

FIG. 10 illustrates a front view of pore matrices according to anembodiment of the present invention;

FIG. 11 illustrates a rear view of an pore matrix according to anembodiment of the present invention;

FIG. 12 illustrates a pore matrix according to an embodiment of thepresent invention;

FIG. 13 illustrates a pore matrix according to an embodiment of thepresent invention;

FIG. 14 illustrates a pore matrix according to an embodiment of thepresent invention;

FIG. 15 illustrates a pore matrix according to an embodiment of thepresent invention;

FIG. 16 illustrates a pore matrix depth according to an embodiment ofthe present invention;

FIG. 17 illustrates a pore matrix depth according to an embodiment ofthe present invention;

FIG. 18 illustrates a pore matrix according to an embodiment of thepresent invention;

FIG. 19 illustrates a pore matrix according to an embodiment of thepresent invention;

FIG. 20 illustrates a pore matrix in spiral form according to anembodiment of the present invention;

FIG. 21 illustrates a pore matrix in spiral form according to anembodiment of the present invention;

FIG. 22 illustrates a pore matrix in concentric circular form accordingto an embodiment of the present invention; and

FIG. 23 illustrates a pore matrix in interspersed circular formaccording to an embodiment of the present invention.

FIG. 24A illustrates an accommodated and a dis-accommodated eye inshowing muscle movement of the eye.

FIG. 24B illustrates the three parts of ciliary muscle and theirrelation to one another in the eye.

FIG. 24C shows contraction of ciliary muscle and its effect on the eye.

FIG. 25 shows a configuration according to at least one embodiment ofthe present invention, where the beam delivery system scans over the eyein a “goniometric” motion.

FIG. 26 shows an isotropic linearly elastic material subjected totension along the x axis with a Poisson's ratio of 0.5. The cube isunstrained while the rectangle is expanded in the x direction due totension and contracted in the y and z directions.

DETAILED DESCRIPTION

The above described figures illustrate the described invention in atleast one of its preferred, best mode embodiments, which is furtherdefined in detail in the following description. Those having ordinaryskill in the art may be able to make alterations and modifications towhat is described herein without departing from its spirit and scope.While this invention is susceptible to embodiment in many differentforms, there is shown in the drawings and will herein be described indetail a preferred embodiment of the invention with the understandingthat the present disclosure is to be considered as an exemplification ofthe principles of the invention and is not intended to limit the broadaspect of the invention to the embodiment illustrated. Therefore, itshould be understood that what is illustrated is set forth only for thepurposes of example and should not be taken as a limitation on the scopeof the present invention, since the scope of the present disclosure willbe limited only by the appended claims.

As used herein and in the appended claims, the singular forms “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosure isnot entitled to antedate such publication by virtue of prior disclosure.Further, the dates of publication provided may be different from theactual publication dates which may need to be independently confirmed.

It should be noted that all features, elements, components, functions,and steps described with respect to any embodiment provided herein areintended to be freely combinable and substitutable with those from anyother embodiment. If a certain feature, element, component, function, orstep is described with respect to only one embodiment, then it should beunderstood that that feature, element, component, function, or step canbe used with every other embodiment described herein unless explicitlystated otherwise. This paragraph therefore serves as antecedent basisand written support for the introduction of claims, at any time, thatcombine features, elements, components, functions, and steps fromdifferent embodiments, or that substitute features, elements,components, functions, and steps from one embodiment with those ofanother, even if the following description does not explicitly state, ina particular instance, that such combinations or substitutions arepossible. It is explicitly acknowledged that express recitation of everypossible combination and substitution is overly burdensome, especiallygiven that the permissibility of each and every such combination andsubstitution will be readily recognized by those of ordinary skill inthe art.

In general, as discussed above, the fundamental and biomechanicalproperties of connective tissue, such as scleral tissue of the eye, maychange over time. These fundamental and biomechanical tissues haveproperties which include, but are not limited to, their structure,function, immunology, elasticity, shock absorption, resilience,mechanical dampening, pliability, stiffness, rigidity, resilience,configuration, alignment, deformation, mobility, volume, biochemistryand molecular genetics of connective tissue proper and newly metabolizedconnective tissue. The alterations of these properties may result in anaccumulation of low grade stress/strain of the connective tissue. Thiscan occur by acute injury or as a normal gradual process of aging. Thealterations of these properties of connective tissue may change theoverall desired properties of the connective tissue and may alsoundesirably affect the surrounding tissues, structures, organs, orsystems related to the connective tissue. Examples of such undesirableaffects are increased tension, loss of flexibility or resilience, alongwith contracture, fibrosis, or sclerosis, any of which can prevent theconnective tissue or structures that are related to the connectivetissue from performing their desired function.

For example, in the human eye, natural alterations in fundamental andbiomechanical properties, specifically resilience, pliability andelasticity of the scleral tissue of the eye may affect the ability ofthe eye to focus. The sclera is the outer layer of the eye and containscollagen and elastic fiber. It is commonly referred to as the “white ofthe eye” and is opaque and protects the eye. These alterations mayaffect the ability of the ciliary muscles and complexes to exert forceson the crystalline lens to affect central optical power (COP). Thesealterations of the scleral tissue may also contribute to an increase inintraocular pressure and to the loss of the contrast sensitivity of theeye or visual field of the eye. Biomechanical and structural alterationsof the sclera may affect the refractive ability as well as theefficiency of the homeostatic functions of the eye such as intraocularpressure, aqueous production, pH, balance, vascular dynamics, metabolismand eye organ function. Furthermore, alterations of the scleral tissuemay contribute to damage to the mechanoreceptors, photoreceptors, orsensory receptors in tissue layers and structures that are directly orindirectly related to the scleral tissue. Additionally, fundamental andbiomechanical alterations of the scleral tissue may also be acontributing factor in the ability of the cerebral cortex to processaccurate visual stimulus necessary for processing visual signals intoaccurate visual perception.

The connective tissue may be any desired connective tissue. For example,in the eye, the pore matrix may be applied to the conjunctiva; thecornea (including all its layers and membranes); the iris; the ciliarybody; the ciliary muscles; the anterior chamber; the zonula ciliaris;the subchoroidal laminathe zonnular ligaments, the lens capsule, theextraocular muscles and their associated connective tissues, membranes,and fascia; the posterior chamber; the lens and all of its associatedlayers, tissues, capsules, and membranes; the canal of schlemm, thetrabecular meshwork and all of its associated layers, tissues, capsules,and membranes; the ora serrata; the vitreous body; the papilla nervioptici; the optic nerve; the lamina cribrosa; the choroid; the sclera;the vitreous and associated membranes; the retina; all epithelial celllayers in the eye; the vascular structures in the eye; the accessoryorgans of the eye; and the lymph vessels of the eye and even the laminacribrosa bony structure surrounding the optic nerve head of the eye.

The present invention described herein relates to the creation of one ormore matrices of pores in the aged connective tissue so as to restorethe lost biomechanical properties of the connective tissue. Suchrestorations include but are not limited to increase in elasticity,resilience, shock absorption, pliability, structural integrity and/ormobility, optimal organ or system function. The pores (or perforations)may be formed via laser ablation or other similar means, and may bemaintained in the connective tissue via the use of a healing inhibitor.Preferably, the matrices are formed in the scleral tissue of the eye.However, it will be appreciated that the present invention may beapplied to other connective or non-connective tissue as the case may bewhere application of the one or more matrices restores lostbiomechanical properties to the tissue. In at least some embodiments, aswill be explained further herein, the one or more matrices may form atessellated pattern of pores in the connective tissue. In at least oneembodiment, the at least one matrices comprises at least one of:anisotropic patterns, fractal patterns, random nano-patterns, or anyother patterns now known or hereinafter developed that may alter theproperties of the connective tissue to improve the biomechanics thereof.

The relationship between the plurality of matrices to one another in aplurality of planes which creates a change in biomechanical propertiesaffecting the tissue resilience, pliability and preferably thevicoelastic properties of the aged connective tissue and creates“negative stiffness”. More physically explained, the connective tissuebiomechanical properties are changed in a specific and unique manner bythe matrices which create tissue resilience. A second biomechanicaleffect of the application of these plurality of matrices is that thetissue properties has have a specific effect on the Poisson ratio—i.e.are changed to a value of negative Poisson ratio. The Poisson ratio (PR)is a fundamental mechanical parameter that approximates the ratio ofrelative change in cross sectional area to tensile elongation. A thirdbiomechanical effect of the application of these plurality of matricesis that the physical and biomechanical changes have a remodeling effecton the connective tissue. A fourth biomechanical effect of theapplication of the plurality of matrices is that the physical andbiomechanical property changes have a negative Poisson's ratio structurewith mechanical isotropy in a minimum of two dimensions. When subjectedto positive strain in a longitudinal axis, the transverse strain in thematerial may actually be positive (i.e. it would increase the crosssectional area).

Laser Surgery System

A surgical laser system 102 for treating connective tissue according toat least one preferred embodiment will now be discussed with particularreference to FIGS. 1-15.

As illustrated for example in FIG. 1, the laser system 102 may be usedto remove scleral tissue by ablating the scleral tissue to formperforations therein. Normal tissue healing may be at least partiallyaffected to maintain the perforations or pores in the scleral tissue. Inother words, forming the perforations may inhibit, disrupt, restrict, orotherwise cause the tissue to deviate from healing, repairing, orregenerating in a manner conforming to the usual or ordinary course ofnature, producing observable deficiencies therein.

The surgical laser system 102 includes a laser head 106 coupled to oneend of a connector such as a laser delivery fiber 120, the opposite endof which is connected to a delivery apparatus such as a hand piece 130.

The laser delivery fiber 120 delivers laser energy from the laseremitter to the hand piece 130. The laser delivery fiber may be of anydesired construction that transfers laser energy from the laser to thehand piece 130. In some embodiments the laser delivery fiber 120 may bea fiber optic assembly. In other embodiments a collimated arm system oran atomized particle beam may be used in lieu of delivery fiber 120, asknown in the art. The connector may deliver energy through an opticalpumped assembly or a fiber to fiber assembly.

Laser 202 may be any desired laser. For example, the laser may be a gastype laser (e.g argon, krypton, CO2, HeNe, Nitrogen, etc.), an excimertype laser (e.g. ArF, KF, KCl, etc.), a solid state type laser (e.g.glass (e.g. fiber optic) crystal (e.g. ruby, YAG, YLF, GSSG, etc.),dopant (e.g. neodymidium, erbium, holmium ytterbium, thulium, chromium,etc.)), a diode type laser, a metal vapor type laser (e.g. Cu, Ag,etc.), or a dye type laser. Preferred wavelengths may range from 193nanometers to 10,600 nanometers. The laser may also be a continuouswave, long pulse, q-switched, or mode locked laser.

In a preferred embodiment, laser 202 has a wavelength of about 2.94 μm.In some embodiments a CO2 laser with a 10.6 micron wavelength may beused. In some embodiments a Ho:YAG laser with a 2.1 micron wavelengthmay be used.

In at least one embodiment, the pulse width of laser 202 may beapproximately 250 μs. In some embodiments “Long Pulse” lasers are usedwith pulse widths in the hundreds of microseconds range. In someembodiments Q-switched lasers with pulse widths in the ten to onehundred nanosecond range are used. In some embodiments Mode-lockedlasers with pulse widths in the tens to hundreds of picoseconds areused. In some embodiments ultrafast lasers with pulse widths in the tensto hundreds of femtoseconds are used. In at least one embodiment, therepetition rate may range from 3 to 50 pps, preferably selected from 3,10, 15, 20, 25, 30, 40 and 50 pps. In some embodiments, the repetitionrate may range from hundreds of hertz to tens of kilohertz. Exemplarylasers are described in the materials appended hereto and are herebyincorporated by reference in their entirety.

Spatial mode structure in embodiments of the invention herein may bevaried. In some embodiments single mode Gaussian spatial mode may beused. In other embodiments multi-spatial mode lasers may be used.

Energy distribution from lasers according to embodiments of theinvention may in some embodiments be Gaussian and in some embodimentsflat-top.

As shown for example in FIG. 2, the delivery system may be configured todirect the laser energy along a path from a beam input location 204 to abeam output location 216. This may be accomplished, inter alia, via aseries of mirrors and/or lenses 204, 208, 210, 212, 214, 216 configuredto direct the laser energy. The series of mirrors and/or lenses may beadjustable either manually, or automatically so as to direct the laserenergy to one or more desired locations.

The delivery system may further be configured to focus the laser energyonto the scleral tissue 140. This may be accomplished, inter alia, via aseries of mirrors and/or lenses 204, 208, 210, 212, 214, 216 configuredto focus the laser energy. The series of mirrors and/or lenses 204, 208,210, 212, 214, 216 may be adjustable either manually, or automaticallyso as to focus the laser energy to one or more desired locations.

The delivery system may also include an image platform, a viewingplatform, a slit lamp, a microscope, or a viewscope 150.

The delivery system 200 may further be configured to cause the laserenergy to form the pore matrix in the scleral tissue.

In at least one embodiment, the delivery system comprises a hand piece130 configured to apply the laser energy in the pore matrix over thetissue. Such application may be manually or automatic. For example, handpiece 130 may be configured to be moved in a pore matrix over the tissuemanually via a trained physician or operator 160.

In some embodiments, the delivery system comprises a scanning mechanismor system (such as eye tracker 304 in FIG. 4) configured to move thelaser energy in the pore matrix over the tissue. This may be anautomated process. For example, in at least one embodiment, the deliverysystem comprises a 2D or 3D galvano-scanning system configured to movethe laser energy in a desired pattern over the tissue. The scanningsystem may also include a reverse imagery device and software platform.As discussed further herein, the scanning mechanism or system directsthe laser ablation beam from pore to pore during formation of the porematrix. Conversely, as also discussed herein, the tracking mechanismmaintains the relative positioning of the scanning system and the targettissue stable. The tracking system is communicatively coupled to thescanning system for at least that reason.

In at least one embodiment, the delivery system comprises a maskconfigured to apply the laser energy in the pore matrix over the tissue.For example, the mask may selectively permit laser energy to reach thescleral tissue.

In some embodiments a mask or film may incorporate a biological,chemical, electrical, ion, or other sensor in order to control numerousparameters of laser beam function and homogenization. In someembodiments a sensor can be incorporated into a mask, film orgalvo-optic assembly to control the gain medium and bandwidth functionof the laser beam. In other words, in some embodiments, the scanningsystem includes a biofeedback control loop. The biofeedback loopprovides real-time feedback about the characteristics of the irradiatedtissue, such as thickness, topography, focus, hydration, etc. In atleast one embodiment, the laser beam used to irradiate the tissue ismeasured to give this feedback and is adjusted based on the real-timetissue characteristics.

In at least one embodiment, the laser and delivery system is anYtterbium Fiber to Fiber system (such as in FIG. 1, element 120) thatdoes not require a crystal. In at least one embodiment, laser 202 has anamplifier that is either in the body piece, the head piece, or remotehand piece 130.

It is important to note, that none of the aforementioned features orembodiments are intended as being mutually exclusive and allcombinations thereof are specifically contemplated. For example, thedelivery system may comprise hand piece 130 having a scanning mechanismtherein to be used in conjunction with a mask.

Turning to FIG. 1, a medical treatment system 100 using a laser system102 is shown that may be used in performing the methods later describedin accordance with the present invention.

In the example embodiment, medical treatment system 100 broadly requiresthe use of laser system 102 which delivers a laser beam via laserdelivery fiber 120 to hand piece 130 and then to patient (also referredto herein as patient's eye) 140. Operator 160 controls laser system 102via foot pedal 114 and laser beam via hand piece 130 and monitorsprogress of a medical procedure via surgical microscope 150.

In the example embodiment laser system 102 is comprised of variouscomponents including system control electronics 104, laser head 106,laser cooling system 108, HV power supply 110, and system power supplies112.

In some embodiments laser cooling system 108 is a water cooling system.In some embodiments laser cooling system 108 may be an air or chemicalsubstrate. Also included may be a user interface button and LED panelincluding status indicators such as on, off, standby, or others. Aninterface exists between laser system 102 and delivery fiber 120.

In the example embodiment laser system 102 creates a laser beam that hasan operational wavelength of 2.94 microns and typical pulse repetitionfrequency of 10-50 Hz. The laser pulsewidth is typically 250microseconds.

Laser system 102 is coupled to hand piece 130 held by operator 160 via afiber optic cable. To transmit mid-infrared light, the fiber material isa chalcogenide glass. It could be made from germanium or ZBLAN.Alternatively, the fiber could be a hollow core fiber, a photoniccrystal fiber, or a double- or multi-clad fiber. Fiber core diameter isabout 400 microns, but could range from single mode to 600 micronsdiameter.

Hand piece 130 interfaces at the proximal end to the fiber cable andcouples the light via focusing optics to a waveguide tip. This tip canbe composed of amorphous glass or crystalline material, such as quartzor sapphire. The diameter of the tip may range from 100 to 600 micronsand may be straight or bent at an angle. The end of the tip may bepolished or cleaved flat or may be angled or rounded. The tip of handpiece 130 is positioned in close proximity to the tissue to be treated.

Hand piece 130 may be passive or active. An active hand piece 130 maycommunicate in some way with laser control system 102 toactivate/deactivate the laser beam, or to change other laser parameters(e.g. pulsewidth, repetition frequency, or pulse energy).

An alternative configuration for hand piece 130 is to contain the actuallaser crystal and cavity. Semiconductor diodes are used rather thanflashlamps to pump the laser crystal and the diode optical energy isdelivered to the laser crystal in handpiece 130 via fiber optics asdisclosed in associated reference patent Shen, U.S. Pat. No. 6,458,120,the entire contents and disclosure of which is herein incorporated byreference.

In some embodiments a hands-free system may be used in place of handpiece 130. In some embodiments a slit lamp interface may be used tomonitor or perform procedures. In some embodiments a supine interfacemay be used as is common in some laser eye surgery procedures.

In the example embodiment surgical microscope 150 is used to providemagnification of the treatment area for operator 160 to guide treatment.In other embodiments surgical microscope 150 may be another viewingapparatus that provides magnification or other vision of the treatmentarea.

Physician or operator 160 may interface with the system in numerousmanners in the various embodiments of the invention. Some embodimentsinclude a touchscreen video monitor. Other embodiments include a videomonitor without touchscreen capabilities. Some embodiments allow for theuse of a keyboard and mouse, hand activated switch, additional footpedals, virtual reality or three-dimensional goggles, remote interactioncapabilities, stereo surgical microscopes, or other related equipment.

In some embodiments a laser crystal is disposed between two reflectivesurfaces and these help form a laser beam. In some embodiments the lasercrystal is a rod crystal or a thin disk crystal. An aperture member maybe positioned between the laser crystal and one of the reflectivesurfaces may include a substantially circular aperture for passing thelaser beam. In many embodiments the size of the aperture is selectivelyadjustable. The aperture member may have a plurality of apertures ofvarious different sizes and is rotatable about an axis of rotation. Theaxis of rotation may be parallel to the longitudinal axis of the lasercrystal. By appropriately rotating the aperture member, a selected oneof the apertures may be positioned to pass the laser beam. In someembodiments, an aperture is used to adjust the laser beam size. Theaperture is located outside the laser cavity. The aperture is locatedrelatively close to irradiation surface. In such embodiments, the laseris preferably a handheld probe diode laser pump crystal.

In some embodiments a stepper motor and flexible shaft are utilized forrotating the aperture member. At least one of the apertures may besurrounded by a beveled portion of the rotatable member.

In some embodiments, two lasers with different size fixed apertures maybe utilized and directed to a common surface. According to an aspect ofthe invention, an articulated arm is provided in some embodiments alongwith one or more refocussing optics for refocussing the laser beam as ittravels through the arm.

In some embodiments, the laser source is provided along with agalvanometer for directing each of two laser beams to a surface to betreated. Such an arrangement may provide additional versatility andcontrol.

In some embodiments, the laser source is provided along a fiberopticalong with a hand piece and one or more focusing optics or tips.According to another aspect, a fourth laser source is provided with asemiconductor disk.

For broad wavelength tuning and for ultrashort pulse generation, otherytterbium-doped gain media may offer a wider gain bandwidth. Examplesare tungstate crystals (Yb:KGW, Yb:KYW, Yb:KLuW), Yb:LaSc3(BO3)4(Yb:LSB), Yb:CaGdAlO4 (Yb:CALGO) and Yb:YVO4. Particularly promising arenovel sesquioxide materials such as Yb:Sc2O3, Yb:Lu2O3 and Yb:Y2O3,having excellent thermo-mechanical properties and a potential for veryhigh output powers and high efficiencies. A slope efficiency of 80% hasbeen demonstrated with Yb:Lu2O3.

Nd:YAG or Nd:YVO4 may also be used in thin-disk lasers, e.g. when awavelength of 1064 nm is required, or when the much smaller saturationenergy of Nd:YVO4 is relevant. Generally, a high doping concentration isdesirable for thin-disk gain media. This allows one to use a rather thindisk (and thus to minimize thermal effects) without arranging for toomany passes of the pump radiation. Most ytterbium doped gain media arequite favorable in this respect.

According to another aspect a fifth laser source is provided with anapparatus wherein said apparatus is part of a stand-alone semiconductorwafer edge-processing system or is a fiber-optic assembly is integratedinto a module for use in a semiconductor wafer edge-processing system. Aunique light amplifier platform to be adapted for laser marking andengraving is found in Ytterbium fiber amplifiers.

In some embodiments the fiber to fiber laser system (such as shown inFIG. 1) comprising of a clad fiber pumping technique creates coherencein the beam structure that closely approaches a Gaussian beam intensityprofile. A method of ablating biological tissue with a laser systemcomprising of a Ytterbium fiber-to-fiber solid state laser wherein theoptical fiber itself is the lasing medium and which contains no lasercrystal or intra-cavity optics near the galvo assembly and the entirebeam steering/galvo mount assembly is reduced to a compact module.

In some embodiments the assembly is a true solid-state design andcomprises of a pumping chamber optics which is grown into the activefiber assembly including a built-in ability of the system toautomatically monitor the output power of the laser source through aself-calibrating feature which constantly provides minute feedback,keeping the output power constant regardless of variations in incomingvoltage or any possible slight degradation of the individual diodes.

In some embodiments, the small package size of the fiber-to-fiber laserallows positioning of the beam in almost any angle, giving an almostunlimited angle spatial treatment area.

In some embodiments, the preferred wavelength of the near-infraredfrequency of Ytterbium fiber at 1060 nm which can be doubled, tripled orquadrupled. Preferably in this invention the 2940 nm wavelengthparameter is presented.

In some embodiments, the laser system comprises a built-in powermonitoring feedback circuits as is known in the art.

In some embodiments the basic laser system is an all fiber format thatallows adjustment of pulse energy and/or change pulse repetition ratewithout affecting any of the output beam parameters.

In some embodiments the basic laser system features a single modeM-squared of <1.2. M-squared is a beam quality metric indicating howclose the laser beam is to a true Gaussian beam.

Provided herein is a method of ablating biological tissue in which thelaser source is a single-frequency, broadly-tunable mid-IR laser.

In some embodiments the laser beam may be positioned with sub-nanometeraccuracy. This may be accomplished with an automated, high resolution,resonant probe AFM instrument that can be connected to a closed loopnano-positioning system. In some embodiments three axis nano-positioningsystems with 100, 200, and 300 micron ranges of motion are provided inall three axes.

Other components may be provided in some embodiments including lasercomponents such as a sensor preamplifier, an Akiyama probe, a mountingboard, and/or a closed loop nano servo controller.

Turning to FIG. 2, an embodiment of a medical treatment system is shownusing a laser treatment system 200 according to an embodiment of thepresent invention.

In the example embodiment, a hands-free laser treatment system 200consists of a treatment laser 202 emitting a laser beam which travelsthrough relay lens 204 to dichroic or flip-in 208. Treatment laser 202is coupled to the system either via a fiber optic, a hollow waveguide,or free space propagation. For free space propagation, the laser beammay be manipulated with fixed mirrors or prisms, or mirrors or prisms onan articulating arm. One or more lenses are used to collimate and/orchange the size of and/or image the laser beam. Additional transportoptics may be used to control the beam as it is brought to the focusingoptics.

In some embodiments active steering elements change the angle of thebeam into the focusing subsystem to scan the focus spot over an area oftissue. These active elements can be galvo, voice coil, DC motor,stepper motor, piezo-driven or MEMS mirrors. Alternatively, the steeringelements could be refractive or diffractive elements, such as Risleyprisms or an electro-, magneto-, or acousto-optic modulators. These arealternatively referred to herein as a scanning system.

In the example embodiment, the beam or beams leave dichroic or flip-in208 and travels to Galvo1 210. Galvo1 210 may consist of a mirror whichrotates through a galvanometer set-up in order to move a laser beam. Thebeam or beams leave Galvo1 210 and travel to Galvo2 212 which may be asimilar setup to Galvo1 210. The beam or beams leave Galvo2 212 andtravel to dichroic (visible/IR) 214. Operator 160 may monitor the beamor beams at dichroic (visible/IR) 214 by using a surgical microscope150. The beam or beams travel from dichroic (visible/IR) 214 throughfocusing optics 216 to patient eye 140.

In some embodiments the tracking system further includes a 3D imagestabilization system for microscopy is provided, capable of controllingtemperature gradients, sample drift, and microscope drift.

In some embodiments focusing optics 216 may include a focusing subsystemfocuses the beam onto the tissue to be treated, creating a focus spotwith desired spot size, energy profile, and focus depth. The focusingsubsystem can consist of refractive, reflective, or diffractiveelements.

In some embodiments visual spotting laser 206 may be a low power laseremployed as a spotting beam to aid visualization of the focus spotlocation on tissue. Visual spotting laser 206 may be a gas, solid stateor semiconductor laser. The preferred embodiment would be a visiblewavelength laser that can be seen with the naked eye or with a siliconCCD or CMOS camera.

Visual spotting laser 206 is injected into the optical system via abeam-splitter dichroic or flip in 208 optic and is preferably collinearto the line of sight of treatment laser 202. Alternatively, an elementthat selectively blocks some of the treatment or spotting laser beam andallows a portion of the other beam to pass could be used so that thespotting and treatment beams are incident on the tissue simultaneously.Alternatively, a rotating or oscillating reflective element thatalternates between the treatment and spotting lasers could be used. Inother embodiments the beams may reach dichroic or flip-in 208 atstaggered times.

It is also possible to have the visible spotting beam integral to thetreatment laser. An example would be to propagate a visible laser beamthrough the intra-cavity mirrors or a solid state laser. Theintra-cavity mirrors could be coated to transmit the spotting laserwavelength while reflecting the treatment laser wavelength.

Alternatively, multiple spotting laser beams may be used and alignedsuch that they are coincident at the focal plane of the focusing optics.If the tissue is not in the focus plane, multiple visible beams will beapparent, indicating the need to adjust focus.

A line of sight for operator 160 to view the area of tissue beingtreatment is injected after the steering elements and before thefocusing subsystem. A beam-splitter dichroic 208 is used so that thetissue may be viewed concurrently with the spotting and/or treatmentlasers 206. It is also possible to employ a reflective element tocombine the treatment/spotting laser lines of sight with the visibleline of sight. This reflective element may create a central obscurationin the laser beam or visible line of sight. Shown in the figure is asurgical, binocular microscope head 150. Instead of a direct visualsystem to the operator's eye, a CCD or CMOS camera with imaging opticscould be employed. This preferably includes a controller for adjustingfor parallax error.

Alternatively, the line of sight could be located after focusing optics216. A similar aperture sharing element as described above could be usedto combine the lines of sight. In this case, separate focusing optics216 would be required for operator 160 to focus on the surface of thetissue such as patient's eye 140.

Turning to FIG. 3, a laser treatment system 300 according to anembodiment of the present invention is shown. FIG. 3 shows the opticalsystem of FIG. 2, with additional subsystems added for monitoring andcontrolling the depth of tissue ablation and for tracking eye movement.

Similar to the embodiment depicted in FIG. 2, in the example embodiment,laser treatment system 300 consists of a treatment laser 202 emitting alaser beam which travels through relay lens 204 to dichroic or flip-in208. Visible spotting laser 206 emits a laser beam which also travels todichroic or flip-in 208. In some embodiments the beams from treatmentlaser 202 and visible spotting laser 206 may meet simultaneously atdichroic or flip-in 208. In other embodiments the beams may reachdichroic or flip-in 208 at staggered times.

The beam or beams leave dichroic or flip-in 208 and travels to Galvo1210. Galvo1 210 may consist of a mirror which rotates through agalvanometer set-up in order to move a laser beam. The beam or beamsleave Galvo1 210 and travel to Galvo2 212 which may be a similar setupto Galvo1 210. The beam or beams leave Galvo2 212 and travel to dichroic(visible/IR) 214. Operator 160 may monitor the beam or beams at dichroic(visible/IR) 214 by using a surgical microscope 150. The beam or beamstravel from dichroic (visible/IR) 214 through focusing optics 216 topatient eye 140.

In FIG. 3, additional monitoring elements are provided for use byoperator 160 to aid in medical procedures. Depth control subsystem 302is coupled to surgical microscope to assist in controlling the depth ofablation procedures in accordance with the present invention. Similarly,eye tracker 304 is coupled to surgical microscope to assist in trackinglandmarks on patient eye 140 during medical procedures in accordancewith the present invention.

Depth control may be achieved by viewing the ablation region andvisually detecting a change in structure or color in the image. A CCDcamera and passive or active illumination may be employed to visualizethe ablation region of patient's eye 140. Image data may be processedand algorithms used to segment the image to determine characteristics ofthe image within a region of interest. These characteristics may becompared to known, stored, or computed values that may be used todetermine when to stop the treatment laser exposure. Alternatively, ameasure of ablation depth may be made and compared to known or storedmaximum depth desired for ablation. Alternatively, the subsurface tissuemay be imaged using, for example, ultrasound or optical coherencetomography. The depth of ablation may be viewed in reference to imagedlandmarks or layers to provide indicators when desired ablation depthhas been achieved.

The region of tissue to be treated must remain positionally stableduring treatment. In the case of the eye, whole body or head movement,as well as ocular movements such as saccades, smooth motion pursuit,vergence, and vestibular-ocular movements must be detected andcompensated. One method of accomplishing this is via imaging of the eyewith a camera, such as a CCD or CMOS camera. Image data can be processedin a variety of ways. One method is to extract features in the imagefield and track changes in position relative to the fixed position ofthe camera pixels. A feedback loop to the steering elements is employedto compensate the line of sight of the treatment beam to maintain itsrelative position on the eye. The imaging camera may be in front of orbehind the steering elements. If it is in front, then the compensationwill run open-loop, in that there is no error signal between thecommanded and resultant position of compensation. If the camera isbehind the steering elements, then the image field of the camera cangenerate a continuous error signal to feedback to the steering elements.If the system has one set of steering elements, then they will be usedboth for scanning the treatment laser beam over tissue and compensatingfor eye motion. Alternatively, two sets of steering elements could beemployed to separate these functions.

Turning to FIG. 3A, a laser treatment system 301 according to anembodiment of the present invention is shown.

In this embodiment, a treatment laser beam travels to dichroic 208. Atdichroic 208 the laser beam travels to Galvo Setup 320 which consists ofGalvo1 210 and Galvo2 212. The beam then passes from Galvo Setup 320 tofocusing optics 216 and ultimately to patient eye 140.

Also provided for in this embodiment is a control and monitoring systemwhich broadly consists of a computer 310, video monitor 312, and camera308. Camera 308 provides monitoring of the laser beam at dichroic 208via lens 306. Camera 308 transmits its feed to computer 310. Computer310 is also operable monitor and control Galvo Setup 320. Computer 310is also coupled to video monitor 312 to provide a user or operator alive feed from camera 308.

In some embodiments of the invention a dual axis closed loopgalvanometer optics assembly is used.

Since multiple lasers systems may be used for treatment in someembodiments, additional laser systems will now be described.

The laser system may include a cage mount galvanometer containing aservo controller, intelligent sensor, feedback system and mount assemblywith an optical camera. Some embodiments may include use of a cage mountgalvanometer optics assembly. Some embodiments may include ultra-highresolution nano-positioners to achieve sub-nanometer resolution.

To expand, FIG. 3A shows more detail of a CCD (or CMOS) camera-based eyetracker subsystem. Dichroic 208 beamsplitter is used to pick off visiblelight, while allowing the IR treatment beam to transmit. Thebeamsplitter 208 is located in front of the steering elements, shownhere as galvo mirrors 320. Lens 306 images the tissue plane (eye) ontothe camera. Features in the image field (e.g. blood vessels, edge of theiris, etc.) are identified by image processing and their coordinates inthe camera pixel field computed. If the eye moves within the pixel fieldframe-to-frame, the change in position of the reference features can becomputed. An error function is computed from the change in referencefeature position and commands issued to the galvo mirrors 320 tominimize the error function. In this configuration, the optical line ofsight is always centered on the treatment spot, which is at a fixedcoordinate in the camera pixel field. The apparent motion fromrepositioning the galvos 320 will be to move the eye image relative tothe fixed treatment spot.

Turning to FIG. 3B, another embodiment of a laser treatment system 303according to an embodiment of the present invention is shown. FIG. 3B issimilar to FIG. 3A, except that the eye tracking subsystem is locatedafter galvo mirrors 320.

In this embodiment, a treatment laser beam travels to Galvo Setup 320which consists of Galvo1 210 and Galvo2 212. The beam then passes fromGalvo Setup 320 to dichroic 208. At dichroic 208 the laser beam travelsto focusing optics 216 and ultimately to patient eye 140.

Also provided for in this embodiment is a control and monitoring systemwhich broadly consists of a computer 310, video monitor 312, and camera308. Camera 308 provides monitoring of the laser beam at dichroic 208via lens 306. Camera 308 transmits its feed to computer 310. Computer310 is also operable monitor and control Galvo Setup 320. Computer 310is also coupled to video monitor 312 to provide a user or operator alive feed from camera 308.

Here, the eye image is shown centered in the pixel field. When eyemotion is detected within the pixel field, the galvos 320 arerepositioned to move the treatment spot to a new position within thepixel field corresponding to the movement of the eye, and to a desiredfixed position relative to the eye reference features.

With reference to the aforementioned biofeedback look, eye trackingincludes in some embodiments includes use of light source producing aninfrared illumination beam projected onto an artificial referenceaffixed to an eye. The infrared illumination beam is projected near thevisual axis of the eye and has a spot size on the eye greater than thereference and covering an area when the reference moves with the eye.

In some embodiments the reference has a retro-reflective surface thatproduces backward scattering orders of magnitude stronger than backwardscattering from the eye would. An optical collector may be configuredand positioned a distance from the eye to collect this backwardscattered infrared light in order to form a bright image spot of thereference at a selected image location.

The bright image spot appears over a dark background with a singleelement positioning detector positioned at the selected image locationto receive the bright image spot and configured to measure atwo-dimensional position of the bright image spot of the reference onthe positioning detector. An electric circuit may be coupled to thepositioning detector to produce positioning signals indicative of aposition of the reference according to a centroid of the bright imagespot based on the measured two-dimensional position of the bright imagespot on the positioning detector.

FIG. 3C illustrates a camera correction system according to anembodiment of the present invention.

In the example embodiment the top row illustrates the camera focuslocation after galvos have been used and the bottom row illustrates thecamera focus location before galvos. Various landmarks 392 may be seenin the example embodiments including capillaries, iris, pupil, etc.Treatment spot 394 may also be seen in each embodiment.

As is shown in the example embodiment the top row of focus before thegalvos each show the pupil of as the center pixel of each image.Compensation after galvos in the bottom row allows the treatment spot394 to remain the focus of the camera's attention in each image andthereby allow the system to remain in position for the associatedprocedure.

Turning to FIG. 3D, a camera-based eye tracker flow diagram 330 isdepicted showing a process according to an embodiment of the presentinvention.

Broadly put, the diagram represents the use of a CCD or CMOS camera tocapture an image of eye. Image data is transmitted to a computer, wherekey features are segmented/extracted (e.g. blood vessels, iris features,edge of pupil). The image is stored as a reference frame. Subsequentimages are then compared to reference frame. A shift is computed aftercomparing reference features in pixel coordinates. Conversion of pixelcoordinates to scanning system coordinates then occurs before commandingthe scanning system to deviate treatment beam line of site to restorerelationship relative to reference features. If the shift is too largeor out of range of scanning system, halt procedure and take steps toreacquire the target image field.

As a more detailed explanation referencing each step, an initializationor starting sequence according to some embodiments requires captureimage frame in step 332 before processing the captured image frame inorder to extract features in step 334. This captured frame withextracted features is then used to set a reference frame in step 336.

After a reference frame is set, step 338 consists of capturing anadditional image frame, called a current frame. This image or currentframe is processed in step 340 in order to extract features. Step 342consists of comparing the current frame to the reference frame which wasset in step 336. An image shift is computed between the current frameand the reference frame in order to determine the difference between theframes. A comparison to a pre-set threshold allows the system todetermine if the image shift exceeds the pre-set threshold and stops theprocedure at this point by going to step 352.

If an image shift does not exceed the pre-set threshold and therefore isnot too large, the system computes a compensation level in step 346 inorder to compensate for the change or shift between the current frameand the reference frame. This compensation level is computed intophysical coordinates used by a scanner in step 348. The scanner is thencommanded to compensate using the coordinates in step 350. After thiscompensation step 338 occurs and another current image frame is capturedand the cycle continues.

Turning to FIG. 3E, a flow diagram for a laser ablation procedure 360embodiment is shown in accordance with the present invention.

Generally put, the procedure flow represents a procedure for steppingthrough, one quadrant at a time, one pore at a time, an ablationpattern. The procedure starts with a patient focused on an off-axisfixation target. A position scanning system locates pore 1 coordinates.Eye tracking is initiated, starting with reference frame. Pore 1 isablated while tracking. The procedure is halted if eye movement is outof range to prevent harm or other negative consequences. Upon completionof pore 1, the position scanning system locates pore 2 coordinates andrepeats the eye tracking and ablation process. These steps are repeateduntil quadrant 1 pattern complete. The fixation target is then moved andpatient focuses on new position and repeat application of ablationpattern on a new quadrant.

As a more detailed explanation referencing each step, in the exampleembodiment a patient is positioned in step 362 in order to receive thetreatment. The patient is then instructed to fixate their gaze for afirst quadrant procedure in step 364.

The line of sight of the laser beam is positioned to a first poreposition in step 366 before a tracker reference is set for the firstpore position in step 368. The user or operator then initiates theablation in step 370 and the first pore is ablated.

The user or operator then moves to step 372 and positions the line ofsight of the laser beam for the second pore position before trackerreference is set for the second pore position in step 374. The user oroperator then initiates the ablation in step 376 and the second pore isablated.

The several steps described in the above paragraph which are similar tothose in the paragraph above it are repeated in step 378 until ablationin the quadrant is complete.

After the quadrant is complete, the patient is instructed to fixatetheir gaze for a second quadrant in step 380 and the process repeats foreach successive quadrant until the procedure as a whole is complete.

Also provided for in the diagram is eye tracking 382 that represents thesteps required and repeated in tracking the position of the eyeconcurrently with the steps of laser ablation procedure flow 360 in theembodiment.

Also provided for in the diagram is eye tracking 384 that represents thesteps required and repeated in tracking the position of the eyeconcurrently with the steps of laser ablation procedure flow 360 in theembodiment.

In some embodiments an eye tracking subsystem may be a camera basedimaging system. This camera based imaging system may be used for imagefeature identification and to assist in tracking position of a laserbeam during a procedure. Feedback from the eye tracking subsystem isprovided to the scanning system to maintain correct position duringprocedures.

In some embodiments the eye tracking subsystem is used for registrationof previously created pores (also referred to as voids) for retreatmentor additional treatment as necessary.

Also provided for in the diagram is depth control 386 that representsthe steps required and repeated in controlling the depth of the laserbeam on the eye concurrently with the steps of laser ablation procedureflow 360 in the embodiment.

Depth control subsystem in some embodiments includes an imaging systemand/or Optical Coherence Tomography. The imaging system may includedetection of a pigmented layer or layers in order to ensure proper depthis reached without exceeding a particular limit.

FIG. 4 illustrates a laser treatment system 400 according to anembodiment of the present invention. In the example embodiment, lasertreatment system 400 consists of a treatment laser 202 emitting a laserbeam which travels through relay lens 204 to dichroic or flip-in 208.Visible spotting laser 206 emits a laser beam which also travels todichroic or flip-in 208. In some embodiments the beams from treatmentlaser 202 and visible spotting laser 206 may meet simultaneously atfirst dichroic or flip-in 208. In other embodiments the beams may reachfirst dichroic or flip-in 208 at staggered times.

The beam or beams leave first dichroic or flip-in 208 and travels to asecond dichroic 208. The beam or beams leave second dichroic 208 andtravel to Galvo1 210. Galvo1 210 may consist of a mirror which rotatesthrough a galvanometer set-up in order to move a laser beam. The beam orbeams leave Galvo1 210 and travel to Galvo2 212 which may be a similarsetup to Galvo1 210. The beam or beams leave Galvo2 212 and travel todichroic (visible/IR) 214. Operator 160 may monitor the beam or beams atdichroic (visible/IR) 214 by using a surgical microscope 150. The beamor beams travel from dichroic (visible/IR) 214 through focusing optics216 to patient eye 140.

In FIG. 4, additional monitoring elements are provided for use byoperator 160 to aid in medical procedures. Depth control subsystem 302assists in controlling the depth of ablation procedures in accordancewith the present invention and receives input from second dichroic 208.Similarly, eye tracker 304 assists in tracking landmarks on patient eye140 during medical procedures in accordance with the present inventionand also receives input from second dichroic 208. Another dichroic 208is shown in the example embodiment splitting the beam with outputs toeye tracker 304 and depth control subsystem 302.

FIG. 4A illustrates a laser treatment system including ablation poredepth according to an embodiment of the present invention.

FIG. 4A generally shows a treatment laser beam traveling to dichroic 208before travelling to Galvo1 210, then to Galvo2 212, through focusingoptics 216, and to patient eye 140.

An OCT system 404 is an Optical Coherence Tomography system used toobtain subsurface images of the eye. As such, when coupled to computer310 which is coupled to video monitor 312, OCT system 404 provides auser or operator the ability to see subsurface images of the tissueablation.

In at least some embodiments OCT provides a real-time, intraoperativeview of depth levels in the tissue. OCT may provide for imagesegmentation in order to identify sclera interior boundary to helpbetter control depth.

OCT system 404 uses an OCT measurement beam, injected into the treatmentbeam line of sight via a dichroic beam splitter 208, located before thescanning system. In this way, the OCT system line of sight is alwayscentered on the pore being ablated. The OCT system is connected to acomputer 310 for processing the images and for control of the laser.

In some embodiments of the invention an anatomy avoidance subsystem isprovided to identify critical biological obstacles or locations duringprocedures (e.g. blood vessels and others). As such, subsurfacevisualization may be provided to identify obstacles such as bloodvessels intra-operatively.

Also shown in FIG. 4A is a simple diagram of an ablation pore in thesclera showing an example of the depth of an ablation in relation to theinner boundary of the sclera.

Turning to FIG. 4B, a flow diagram of OCT-based depth control 410 isshown according to an embodiment of the present invention.

In general, The OCT system executes a repetitive B-scan, synchronizedwith the laser. The B-scan shows the top surface of the conjunctivaand/or sclera, the boundaries of the pore being ablated, and the bottominterface between the sclera and the choroid or ciliary body. Automaticimage segmentation algorithms are employed to identify the top andbottom surfaces of the sclera (typically 400-1000 microns thick) and theboundaries of the ablated pore. The distance from the top surface of thesclera to the bottom surface of the pore is automatically computed andcompared to the local thickness of the sclera. In some embodiments thisoccurs in real time. When the pore depth reaches a predefined number orfraction of sclera thickness, ablation is halted and the scanning systemindexed to the next target ablation location. In some embodiments imagesmay be segmented to identify interior sclera boundaries.

With reference to the steps in the figure, in the example embodiment astarting or initialization set of steps occurs first. This starting setof steps begins with positioning to a pore coordinate in step 412. AB-scan of the target region occurs in step 414. This scan creates animage which is processed in step 416 in order to segment and identifythe sclera boundary. A distance is then computed in step 418 between theconjunctive surface and the sclera boundary.

After completion of this starting set of steps ablation is initiated instep 420. A laser beam pulse is fired in step 422 followed by a B-scanin step 424. This B-scan creates an image that is then segmented in step426 and pore depth and ablation rate are computed from the image. Thispore depth and ablation rate are compared to the target depth in step430. If the target depth has not been reached then the process loopsback to step 422 and repeats. Upon reaching a target depth step 432stops the ablation process and the starting process begins again at step434 with positioning to a next pore coordinates.

FIG. 5A-FIG. 5C show various means of coupling the treatment laser intothe optical system.

Turning to FIG. 5A, a laser treatment system lens placement is shownaccording to an embodiment of the present invention. In the exampleembodiment the laser beam emitted from treatment laser 202 travelsthrough a waveguide, either hollow or fiber. These were described abovein depth in FIG. 1.

Turning to FIG. 5B, a laser treatment system lens placement is shownaccording to an embodiment of the present invention. In the exampleembodiment free space propagation is shown. A multi-lens collimatingtelescope can serve to change the size of the beam (expand or reduce) aswell as image the beam waist or output aperture of the laser beam tosome location in the optical system. Shown here is a so-called Keplarianconfiguration, where a real focus is formed inside the telescope.

Turning to FIG. 5C, a laser treatment system lens placement is shownaccording to an embodiment of the present invention. In the exampleembodiment, an aperture is used similar to the embodiment in FIG. 5Bexcept that this embodiment uses a Galilean configuration telescope witha negative and a positive element rather than a Keplarian configuration.This configuration does not form a real image within the telescope. Thisoptical configuration is also known as a telephoto or reverse telephotoconfiguration (depending on orientation), which can be important whenconsidering the desired position of the beam waist or laser beam outputaperture in the system.

FIG. 6 illustrates a laser treatment system component map 600 showingrelation of related subsystems according to an embodiment of the presentinvention.

In general laser treatment system component map 600 shows a laser 602, alaser delivery fiber 120, laser control system 604, monitoring system608, and beam control system 606.

Laser 602 is generally made up of several subsystems. In the exampleembodiment these subsystems include system control electronics 104,Er:YAG laser head 612, laser cooling system 108, HV power supply 110,and system power supplies 112. Foot pedal 114 provides some control forthe system user. Laser 602 transmits a laser beam via laser deliveryfiber 120 to beam control system 606.

Beam control system 606 is generally made up of beam transport optics624, red spotting laser 626, galvo mirrors 628, beam delivery optics630, and active focus 632.

Laser control system 604 maintains a link to laser 602 via a laser syncand to beam control system 606 via power control position status. Lasercontrol system 604 is generally made up of a user interface 614, powersupply 616, galvo controller 618, galvo controller 620, andmicrocontroller 622. Laser control system 604 is also manipulable viajoystick 610.

Monitoring system 608 is generally made up of CCD camera 634 and visualmicroscope 636.

In some embodiments a fiber laser is used which is composed of anundoped cladding and a doped core of higher refraction. The laser beamtravels through the fiber guided within the fiber core and experiences ahigh amplification due to the length of interaction. Fiber lasers areconsidered advantageous to other laser systems because, among otherqualities, they have simple thermal management properties, high beamquality, high electrical efficiency, high optical efficiency, high peakenergy, in addition to being low cost, requiring low maintenance, havingsuperior reliability, a lack of mirror or beam path alignment, and theyare lightweight and generally compact.

In some embodiments of the invention spot arrays may be used in order toablate multiple pores at once. These spot arrays may, in some cases, becreated using microlenses and also be affected by the properties of thelaser. A larger wavelength may lead to a smaller number of spots withincreased spot diameter.

Turning to FIG. 7, a laser treatment system 700 is shown according to anembodiment of the present invention.

Laser treatment system 700 is generally made up of control system 702,optics and beam controls.

Control system 702 includes monitor1 704 and monitor2 706 as well askeyboard 708 and mouse 710 to provide a user the ability to interact andcontrol with a host computer 724 running computer programs. In manyembodiments the computer programs running on host computer 724 includecontrol programs for controlling visible spotting laser 712, laser head714, laser cooling system 716, system power supplies 718, laser powersupply 720, and beam transport optics 722.

Also provided for in this embodiment are depth control subsystem 726,galvo mirrors 728, CCD Camera 730, visual microscope 732, focussubsystem 734, and beam delivery optics 736.

Preoperative measurement of ocular properties and customization oftreatment to an individual patient's needs is beneficial in manyembodiments. Preoperative measurement of ocular properties may includemeasuring intraocular pressure (IOP), scleral thickness, scleralstress/strain, anterior vasculature, accommodative response, andrefractive error. Measurement of scleral thickness may include use ofoptical coherence tomography (OCT). Measurement of scleral stress/strainmay include using Brillouin scattering, OCT elastography, photoacoustics(light plus ultrasound). Measurement of anterior vasculature may includeusing OCT or Doppler OCT. Measurement of refractive error may includeusing the products such as the iTrace trademarked product from TraceyTechnologies Corp.

Intraoperative biofeedback loops may be important during the procedurein order to keep the physician informed on the progress of theprocedure. Such feedback loops may include use of topographicalmeasurements and monitoring “keep away” zones such as anterior ciliaryarteries.

Biofeedback loops may include a closed-loop sensor to correct fornonlinearity in the piezo scanning mechanism. The sensor in someembodiments may offer real-time position feedback in a few millisecondsand utilizing capacitive sensors for real-time position feedback.Sensor/feedback apparatus may also perform biological or chemical “smartsensing” to allow ablation of target tissue and protect or avoidsurrounding tissue. In some instances this smart sensing may beaccomplished by using a biochip incorporation in a mask which isactivated by light irradiation and senses location, depth, size, shape,or other parameters of an ablation profile. Galvo-optic assemblies arealso contemplated in some embodiments and may be used to gage numerousparameters of laser steering and special function.

FIG. 8 illustrates an eye treatment map 800 according to an embodimentof the present invention.

In the example embodiment sclera 802 is shown broken into fourquadrants. Limbus 804 is located aside from ablative pore locations 806.As procedures in many embodiments of this invention are completed byquadrants, only a first quadrant is shown however each additionalquadrant will have similar mapping.

FIGS. 9-11 illustrates exemplary pore matrices according to preferredembodiments of the present invention. Patient eye 900 has pupil 902,iris 904, and sclera 906. The pore matrices comprise a plurality ofpores 912 formed in first ablation pattern location 908 and secondablation pattern location 910.

In at least one embodiment, the connective tissue is the sclera of theeye, and the delivery system comprises a spacer/fixator configured tofix the delivery system relative to the eye, and a corneal shieldconfigured to be placed over the cornea so as to block laser energy frombeing applied thereto. In some embodiments the spacer/fixator may bedetachable and/or disposable. The delivery system may then form the porematrix in the sclera of the eye.

In at least one embodiment, the fixator includes a track along which thedelivery system can move relative to the eye. The laser energy isselectively delivered to the scleral tissue therethrough to form one ormore matrices of the pore matrix at a first location of the scleraltissue. Then, the delivery system is relocated so that the laser energymay be selectively delivered to the scleral tissue at a second locationof the scleral tissue. In this way, tessellated matrices may be formed.

The eye spacer/fixator is an adjustable dual cylinder shaped apparatusthat accommodates the anterior globe of the sclera where a centralcylinder excludes the cornea from a treatment zone and where a peripherycylinder includes a scleral treatment zone up to a 6-7 mm radius.

A scleral fixator may be attached to the inferior surface of the dualcylinder assembly and may have four fixator prongs at1:30-4:30-7:30-10:30 and the fixator may be detachable and disposablefrom a treatment spacer bar.

In some embodiments there may be a corneal shield or plate which can betinted to protect associated portions of the eye.

In at least one embodiment, the delivery system contains a sensor with afeedback configured to control depth, spot size and dynamic control ofthe delivery system, and energy parameters of the laser beam delivery.

In at least one embodiment, the delivery system contains a transmittercommunicatively coupled to a satellite unit that communicates with thebase unit—preferably by Radio frequency or blue tooth or WIFI—regardingthe tissue parameters and has a dynamic control which communicates withthe laser. Such communication may include delivery parameters and shutoff features.

In some embodiments accessories may be provided for use with the mainsystem and device disclosed herein. These accessories may include, inaddition to the detachable and/or disposable eye spacer/fixatordescribed above, a disposable eye suction ring for use with an eyemodule. The eye suction ring may be used in a complementary orsupplementary role with the eye spacer/fixator or, in some embodiments,as a replacement.

In some embodiments a sterile “docking station” may be provided for slitlamp-type configuration of the procedure.

Ablation Patterns

A method of use of the invention will now be discussed with reference tothe figures. As mentioned previously, the main purpose of the method isto modify the biomechanical properties of the tissue, particularly thesclera. This modification allows the pars plicata of the ciliary body tomove upward and inward on contraction of the ciliary muscle,compensating for an increase in choroidal and/or scleral stiffness withage and also potentially enables corneal accommodation.

As shown in FIGS. 9 to 23, ablation patterns are formed in variousconfigurations on a patient's eye in accordance with the invention.

Ablation patterns are formed by the laser beam during the procedure.These are also referred to herein as pore matrices.

A pore matrix is formed of a plurality of perforations scleral tissue ofa patient. By being located in the scleral tissue according to the porematrix, the perforations interact with and affect the fundamentalmechanisms involved in the immunology, biochemistry and moleculargenetics of scleral tissue metabolism. Indeed, tension or resilience inthe scleral tissue is modified in such a way that reduces naturaldegradation of physiological, biomechanical, and biologic function ofthe tissues and organ. This in turn helps restore mechanical efficiencyof the natural accommodative mechanism in optical focus and improvesbiomechanical mobility to achieve this accommodative power.

The perforations may be formed by any means now known or laterdeveloped. Such means may, for example, ablate, excise, incise,vaporize, remodel or puncture the scleral tissue to create theperforations. Although the pores or perforations in the scleral tissueare generally described herein as being formed by ablating the tissueusing laser energy, it is contemplated that the perforations could beformed using any desired surgical tool, such as a diamond knife, rubyknife, or a radio frequency device, or a nano device, robotics, achemical application, electrical application or a substrate waferapplication.

In many embodiments the increase in pliability, resilience, andrestoration of viscoelastic properties caused by successful ablation bythe methods disclosed herein induces a “negative stiffness” or Poisson'seffect in the tissue. Poisson's effect is described as the negativeratio of transverse to axial strain in a material. That is to say, thatwhen a material is compressed in one three-dimensional direction thatthe material tends to expand in the other two three-dimensionaldirections. Conversely, if a material is stretched in onethree-dimensional direction then the material compresses in the othertwo three dimensional directions. This is beneficial in the case wheretissue has become stiff because an increase in its ability to stretch orcompress allows for a greater range of movement and greaterbiomechanical adaptability.

Ablation by the methods disclosed herein may be considered to have aremodeling effect on the tissue being ablated since it is inherentlychanging the properties of the tissue. This remodeling effect createsmechanical isotropy in a minimum of two dimensions. That is to saymechanical properties are identical in at least two dimensions as aresult of successful ablation.

In some cases, additional positive results may be observed as a resultof successful ablation. These may include improved physiologicalinteraction between pores including improved ion exchange, separationcatalysis, as well as improved biological, chemical, and molecularpurification and processing.

FIG. 12-FIG. 19 will now be described in detail. For each of FIG.12-FIG. 19, the region shown varies from Limbus to Ora Serrata in onequadrant of the eye. The edge of the treatment zone is 0.5 mm from thelimbus and nominally extends down 5.5 mm towards the Ora Serrata. Eyedimensions vary with race, patient to patient and with orientationaround the globe (Temporal, Superior, Nasal, Inferior).

The treatment region is divided radially into zones correlating toanatomy. Zone 1: Ciliary body Pars Plicata; Zone 2: Ciliary body ParsPlana; Zone 3: Transition of ciliary body to Ora Serrata. This isdescribed in further detail below in FIGS. 24A-C.

Aside from the exterior boundaries of the patterns, the main differencesin the patterns are regular grids (e.g. FIG. 12) versus an“interspersed” grid (e.g. FIG. 14). In the regular grid, 4 pores formthe vertices of a square, whereas in the interspersed grid, 3 pores formthe vertices of an equilateral triangle.

Turning to FIG. 12, a pore matrix map according to an embodiment of thepresent invention is shown.

FIG. 12 generally shows distance map 1200 including excision locations1202. In some embodiments excision locations 1202 include nine locationsper oblique quadrant of the eye in a mathematical diamond matrixpattern. Excision locations are set to six-hundred micrometer sizes andare ablated using an Er:YAG laser. The process is completed until eachoblique quadrant has been completed. In some embodiments the quadrantsneed not be oblique.

FIG. 13 illustrates a pore matrix according to an embodiment of thepresent In some embodiments excision locations 1302 include ninelocations per quadrant of the eye in a mathematical angle matrixpattern. Excision locations are set to six-hundred micrometer sizes andare ablated using an Er:YAG laser. The process is completed until eachquadrant has been completed.

FIG. 14 illustrates a pore matrix according to an embodiment of thepresent invention. In some embodiments excision locations 1402 includenine locations per quadrant of the eye in a mathematical chevron matrixpattern. Excision locations are set to six-hundred micrometer sizes andare ablated using an Er:YAG laser. The process is completed until eachquadrant has been completed.

FIG. 15 illustrates a pore matrix according to an embodiment of thepresent invention. In some embodiments excision locations 1502 includeten locations per quadrant of the eye in a mathematical horizontalhexagonal matrix pattern. Excision locations are set to six-hundredmicrometer sizes and are ablated using an Er:YAG laser. The process iscompleted until each quadrant has been completed.

FIG. 16 illustrates a pore matrix according to an embodiment of thepresent invention. In some embodiments excision locations 1602 includeten locations per quadrant of the eye in a mathematical verticalhexagonal matrix pattern. Excision locations are set to six-hundredmicrometer sizes and are ablated using an Er:YAG laser. The process iscompleted until each quadrant has been completed.

FIG. 17 illustrates a pore matrix according to an embodiment of thepresent invention. In some embodiments excision locations 1702 includefifteen locations per quadrant of the eye in a mathematical triangularmatrix pattern. Excision locations are set to six-hundred micrometersizes and are ablated using an Er:YAG laser. The process is completeduntil each quadrant has been completed.

FIG. 18 illustrates a pore matrix according to an embodiment of thepresent invention. In some embodiments excision locations 1802 includefifteen locations per quadrant of the eye in a mathematical wave matrixpattern. Excision locations are set to six-hundred micrometer sizes andare ablated using an Er:YAG laser. The process is completed until eachquadrant has been completed.

FIG. 19 illustrates a pore matrix according to an embodiment of thepresent invention. In some embodiments excision locations 1902 includelocations per quadrant of the eye in a mathematical decagon matrixpattern. Excision locations are set to six-hundred micrometer sizes andare ablated using an Er:YAG laser. The process is completed until eachquadrant has been completed.

Turning to FIG. 20-FIG. 21, examples of pores tracing out “golden”spirals—clockwise, counterclockwise and combined are shown. A goldenspiral is a logarithmic spiral that grows by a factor of φ (the goldennumber; φ=1.618) for each quarter turn of the spiral. This is a form ofspiral commonly found in nature. This “golden” spiral pore matrix is thepreferred embodiment. In other embodiments other types of spirals couldbe used as well.

Spiral and circle patterns in accordance with the invention generallydemonstrate a transition from quadrant-based treatment to completecircumferential treatment.

FIG. 20 illustrates pore matrices in spiral form according toembodiments of the present invention. According to the exampleembodiment patterns 2000 are made of pores 2002.

FIG. 21 illustrates a pore matrix in spiral form according to anembodiment of the present invention. According to the example embodimentpatterns 2100 are made of spirals 2102. Spirals 2102 are in turn made ofpores (not shown in the current embodiment).

FIG. 22 illustrates a pore matrix in concentric circular form accordingto an embodiment of the present invention. According to the exampleembodiment patterns 2200 are made of pores 2202.

These concentric circles are shown emanating from limbus to ora serrata.Each circle shown here has pores with equal angular spacing. In someembodiments patterns may also be created with equal pore to pore lateralspacing. In some embodiments every other circle shifted by one half ofthe pore spacing rotationally to produce an “interspersed” pattern.

FIG. 23 illustrates a pore matrix in interspersed circular formaccording to an embodiment of the present invention. According to theexample embodiment patterns 2300 are made of pores 2302.

The pore matrix is such that the fundamental biomechanical properties ofthe scleral tissue may be improved by formation of the pore matrixtherein. The pore matrix may consist of one or more regularly spacedarrays of perforations. The pore matrix may also comprise one or morematrices, each matrix comprising one or more regularly spaced arrays ofperforations. That is, the pore matrix is comprised of one or morematrices, which is comprised of one or more regularly spaced arrays ofperforations in the scleral tissue. Various pore matrices arecontemplated, some non-limiting examples of which are described above.Other exemplary pore matrices are described in the materials appendedhereto and are hereby incorporated by reference in their entireties.

The pore matrix may be a tessellated pore matrix. That is, the porematrix may comprise a plurality of matrices repeating with no gaps andno overlap. Although patterns shown in the drawings are discretized,showing a specific number of ablations in specific patterns, thedrawings are not exhaustive. As such, numerous other regular orinterspersed grid patterns are contemplated and different spirals,concentric circles, three dimensional, and even other irregular orperturbed patterns are contemplated. Pore characteristics may be highlyvariable in additional embodiments of the invention, not specificallydescribed here.

In some embodiments, the pores or perforations may extend through theentire depth or thickness of the scleral tissue, or substantiallytherethrough. Accordingly, the tissue may be ablated through an infinitenumber of planes of the tissue. Alternatively, the pore matrix may beformed in multiple discrete planes of the scleral tissue. Indeed, itsubsurface pore matrices are specifically contemplated. Thus, forexample, pore matrices of n×m×1 matrices may be formed.

Additionally, the perforations may be formed according to differentsizes and shapes. These may include cylindrical, cone-shaped, square,rectangular, pyramidal, and others.

Turning to FIG. 24A, an illustration of an accommodated eye 2401 and adisaccommodated eye 2402 and associated muscle movement of the eye isshown. FIG. 24A generally shows ciliary muscle 2404, lens 2406, parsplicata portion 2408 of ciliary body, cornea 2410, zonules 2412, andsclera 2414. In FIG. 24A, accommodated eye 2401 and disaccomodated eye2402 are shown, the changes between the two described below.

The relaxed, or disaccommodated eye 2402 is shown on the right. Theciliary muscle 2402 is relaxed and the zonules 2412 are pulled taut,flattening (thinning) the lens 2406 for distance vision and lower power.

The accommodated eye 2401 is shown on the left. Here, the ciliary muscle2404 is contracted, relaxing the tension on the zonules 2412 andallowing the crystalline lens 2406 to take its more natural, curvedshape for near vision. Lens 2406 in this configuration may also bereferred to as steeper or thicker. Also, the pars plicata 2408 of theciliary body moves inward.

Zonules 2412 are variously known as suspensory ligaments, zonules ofZinn, and zonnular apparatus. Zonular fibers that attach to the lens areanterior, central, and posterior. Ciliary muscle 2402 is containedwithin the ciliary body.

FIG. 24B illustrates the three parts of ciliary muscle and theirrelation to one another in the eye. Ciliary body 2414 contains ciliarymuscle. Ciliary muscle includes Circular Ciliary Muscle Fibers 2416,Radial (Oblique) Ciliary Muscle Fibers 2418, Longitudinal (Meridonal)Ciliary Muscle Fibers (aka Bruke's Muscle) 2420, and “Epichoroidal Star”attachment 2422. Also shown is sclera spur 2424 of sclera 2414.

These muscles are generally grouped into three types, circular, radialand longitudinal. The radial and longitudinal muscle fibers terminate inthe scleral spur 2424. The longitudinal muscle fibers terminate in“epichoroidal stars” 2422 for attachment to the choroid layer 2426 atthe ora serrata 2428.

FIG. 24C is corneo-scleral shell with the ciliary body 2414 showingcontraction of ciliary muscle and its effect on the eye. Shown in FIG.24C is the increase in the bundle cross section of Circular CiliaryMuscle Fibers 2416 as the contraction of ciliary muscles stretcheschoroid 2426 and causes inward/upward movement of pars plicata 2408,relaxing zonules 2412. More particularly, when the ciliary musclecontracts, the longitudinal fibers stretch the choroid and pull oraserrata 2428 up. The end of the ciliary body 2414 close to the scleralspur 2424 is called the pars plicata 2408. As the ciliary musclecontracts, the pars plicata 2408 moves inward and upward. This relaxesthe tension on the zonules 2412 attached to the crystalline lens 2406,allowing lens 2406 to take a steeper shape for near vision. As discussedabove, aging generally impairs the biomechanical properties of thescleral tissue and so impedes the above described functionality of thesclera with respect to accommodation. Formation of the aforementionedpore matrices in the scleral tissue in accordance with the embodimentsdescribed herein restore the biomechanical properties of the scleraltissue that were impaired by age.

Ablation creates pliable matrix zones in the sclera and in the exampleembodiment micro-excisions are created in three critical zones over theciliary complex. However, matrix zones are not limited to twodimensional matrices. In many embodiments of the invention the matrixzones are three dimensional. Also provided are treatments whereinlocations may be reached within the tissue without ablating regionsabove the tissue. That is, a location with x, y, z coordinates in thetissue may be reached without ablating any or all tissue in the threedimensional space to get to the x, y, z coordinate location.

In some embodiments the living tissue matrix creates a hyperbolic planeof tissue having a differential tissue plane within a plurality of porematrices being anisotropic, tessellated and within a mathematical arrayexists. Additionally, particular matrices chosen may effect biologicalor biomechanical reactions.

In some embodiments pores may be nanopores which are less than twonanometers in diameter, neopores which are between two and fiftynanometers, or macropores which ware greater than fifty nanometers indiameter. Pores may generally be between one and one hundred nanometers.

Some embodiments of the invention provide for a high surface to volumeratio ordered uniform pore structure throughout a plurality of planes.In general there is a specificity of pore size, shape and distributionin the matrix used in an embodiment and pores are specifically andmathematically arranged in a matrix.

In some embodiments the specificity of a pore pattern may be a fractal.In some embodiments the specificity of a pore wall morphology isintegral. Pore walls contain an inner wall, an outer wall, andinterstitial space which may occur at a plurality of depths, angles, andplanes through several layers of tissue.

Some pre configurations have a three dimensional architecture ofparticle aggregates. The biomechanical properties of a tissue crosssection where matrices are placed may be effected by porosity such asthe equation f=VfNt or F=Va+Vu/Vs+Va+Vw where there is a surface volumeratio diameter and depth distribution of the pore relationship withinthe plurality of matrices of Fv=−(dV/dD) where V=pore Volume and D=poreDiameter.

As another example, in the ear, the surgical laser system may be used totreat the tympanic membrane, the crista ampullaris, the cochlear, thecochlear duct, and hair cells. As another example, the surgical lasersystem may be used to treat tissue of the kidneys or tissue of theovaries. As another example, the surgical laser system may be used totreat large aponeuroses, such as lumbosacral fascia, abdominal raphe,and neural sheath in the spinal cord. As yet another example, thesurgical laser system may be used to treat bones, cartilage, ligaments,and tendons. As still another example, the surgical laser system may beused to treat the brain, such as dura matter of the brain and the bonysurroundings of the brain. As another example, the surgical laser systemmay be used to treat lymph node CT or spleen CT. As another example, thesurgical laser system may be used to treat vascular vessels and/or theheart as well as the surrounding tissue such as the pericardium. As afurther example, the surgical laser system may be used to treat muscles.

FIG. 25 shows a configuration where the beam delivery system scans overthe eye in a “goniometric” motion—that is the beam delivery systemtraces an arc with an offset center of curvature. In this case, thecenter of curvature is at the center of the treated eye. This allows thenominal line of sight from the beam delivery system to maintainperpendicularity to the surface of the sclera. The motion of the beamdelivery system can be along either or both of two axes, labeled withthe alpha and beta angles in the drawing. The galvo scanners can be usedto scan locally within an angular neighborhood of theta, to place spotsin the (annular) treatment zone while maintaining perpendicularity ofthe line of sight to the scleral surface.

The effects of ablation may be seen in many of the structures of theeye. For instance, the ciliary muscle is a ring of striated smoothmuscle that controls accommodation for viewing objects at varyingdistances. In simpler terms, it helps in focusing of the eye. Some ofthe mechanisms used include regulating flow of aqueaous humour intoSchlemm's canal and changing the shape of the lens within the eye (butnot the pupil size which is affected by a different muscle). Ablation ofscleral tissue as performed in numerous embodiments in this descriptioncauses a decrease in scleral resistive forces. This decrease in scleralresistive forces in turn increases ciliary muscle resultant forces andallows for improved focusing and restoration of dynamic accommodationwithin the eye.

In some instances near and intermediate vision and both uncorrected anddistance corrected vision improves as a result of the methods describedherein.

Healing Inhibition

The perforations may have inner walls that are spaced from each other adistance that alters the fundamental mechanisms involved in theimmunology, biochemistry and molecular genetics of scleral tissuemetabolism in such a way as to inhibit normal tissue healing, repair, orregeneration to prevent total healing of the perforations in the scleraltissue. The inner walls of the perforations may be spaced from eachother by a distance greater than 400 μm. It is also contemplated thatthe inner walls of the perforations may be spaced from each other by adistance greater than 600 μm. It is also contemplated that the innerwalls of the perforations may be spaced from each other by a distancegreater than 200 μm. It is also contemplated that the size of theperforations can range from 0.001 to 1 um. Preferably, the perforationsize is determined by the proportion of removed tissue to remainingtissue in the target tissue. For the perforations of the pore matrix,there may be a positive correlation of the perforation area to theresidual interstitial tissue—in other words, the perforation maycomprise a complete negative space. Additionally, for the perforationsof the pore matrix, the perforation may comprise a negative, or reversepattern, where the perforation may comprise a negative spaceencapsulating a positive space—in other words, the perforation maycomprise an outline of remaining interstitial tissue. Preferably, suchreverse perforations comprise rings surrounding interstitial tissue.

The perforations may be filled with a scarring inhibitor substance suchas a porous collagen-glycosaminoglican scaffold. An example of such aporous collagen-glycosaminoglican scaffold is made by Mediking under thetrade name OccuusGen. Alternatively, the perforations may be filled witha biological glycoprotein or a synthetic glycoprotein. As anotheralternative, the perforations may be filled via the application of abiologically compatible product, which can be in the form of a liquid, agel, or a porous solid. The perforations may also be treated with asealant. An example of such a sealant is made by Johnson and Johnsonunder the tradename Band-Aid® brand liquid bandage; and a similarproduct is made by Spenco under the tradename 2nd Skin® and OcuSeal™Liquid Ocular BandageAs a further alternative, the perforations may befilled via application or treatment to facilitate an ionic reaction,chemical reaction, photonic reaction, organic reaction, inorganicreaction, electronic reaction, or a combination of these reactions todisrupt normal tissue healing. One such preferred embodiment would be toutilize anti fibrotic or other wound healing prevention agent in theform of a collagenous contact lens or biodegradable material. Anothersuch preferred embodiment would be to utilize a biochemical to inhibitwound healing or a biological synthetic to inhibit wound healing.

The enablements described in detail above are considered novel over theprior art of record and are considered critical to the operation of atleast one aspect of the invention and to the achievement of the abovedescribed objectives. The words used in this specification to describethe instant embodiments are to be understood not only in the sense oftheir commonly defined meanings, but to include by special definition inthis specification: structure, material or acts beyond the scope of thecommonly defined meanings. Thus if an element can be understood in thecontext of this specification as including more than one meaning, thenits use must be understood as being generic to all possible meaningssupported by the specification and by the word or words describing theelement.

The definitions of the words or drawing elements described herein aremeant to include not only the combination of elements which areliterally set forth, but all equivalent structure, material or acts forperforming substantially the same function in substantially the same wayto obtain substantially the same result. In this sense it is thereforecontemplated that an equivalent substitution of two or more elements maybe made for any one of the elements described and its variousembodiments or that a single element may be substituted for two or moreelements in a claim.

Changes from the claimed subject matter as viewed by a person withordinary skill in the art, now known or later devised, are expresslycontemplated as being equivalents within the scope intended and itsvarious embodiments. Therefore, obvious substitutions now or later knownto one with ordinary skill in the art are defined to be within the scopeof the defined elements. This disclosure is thus meant to be understoodto include what is specifically illustrated and described above, what isconceptually equivalent, what can be obviously substituted, and alsowhat incorporates the essential ideas.

The scope of this description is to be interpreted only in conjunctionwith the appended claims and it is made clear, here, that the namedinventor believes that the claimed subject matter is what is intended tobe patented.

What is claimed is:
 1. A device for delivering ablative medicaltreatments to improve biomechanics comprising: a laser for generating abeam of laser radiation used in ablative medical treatments to improvebiomechanics; a housing; a controller within the housing, incommunication with the laser and operable to control dosimetry of thebeam of laser radiation in application to a target material; a lensoperable to focus the beam of laser radiation onto a target material;and a power source operable to provide power to the laser andcontroller.
 2. The device for delivering ablative medical treatments toimprove biomechanics of claim 1, further comprising: a scanner operableto monitor a position of the laser during the medical treatment and sendposition information to a processor; the processor operable to receiveand use the position information to calculate whether a treatmentlocation has moved; the processor operable to reconfigure the positionof the laser if the treatment location has moved; and the processoroperable to stop the medical treatment if the treatment location hasmoved a distance greater than a preselected threshold distance.
 3. Thedevice for delivering ablative medical treatments to improvebiomechanics of claim 1, further comprising: a scanner operable tomonitor a depth of an ablation during the medical treatment and senddepth information to a processor; the processor operable to receive anduse the depth information to calculate whether a treatment depth hasreached a threshold; the processor operable to allow continuation of themedical procedure if the treatment depth has not reached the threshold;and the processor operable to stop the medical treatment if thetreatment depth has reached or exceeded the threshold.
 4. The device fordelivery ablative medical treatments to improve biomechanics of claim 1,wherein the laser further comprises a flash lamp, a high powered diode,and an optical pump.
 5. A method of delivering ablative medicaltreatments to improve biomechanics comprising: using a laser to generatea treatment beam in a treatment to improve biomechanics; wherein acontroller, in electrical communication with the laser, is used tocontrol dosimetry of the treatment beam in application to a targetmaterial; wherein a lens is used to focus the treatment beam onto thetarget material; and wherein a power source is used to provide power tothe laser and the controller.
 6. The method of delivering ablativemedical treatments to improve biomechanics of claim 5, furthercomprising: using a scanner to monitor a position of the treatment beamduring the treatment and send position information to a processor;wherein the processor receives and uses the position information tocalculate whether a treatment location has moved; wherein the processorreconfigures the position of the treatment beam if the treatmentlocation has moved; and wherein the processor halts the medicaltreatment if the treatment location has moved a distance greater than apreselected threshold distance.
 7. The method of delivering ablativemedical treatments to improve biomechanics of claim 5, furthercomprising: using a scanner to monitor a depth of an ablation during thetreatment and sending depth information to a processor; wherein theprocessor receives and uses the depth information to calculate whether atreatment depth has reached a threshold; wherein the processor allowscontinuation of the procedure if the treatment depth has not reached thethreshold; and wherein the processor halts the treatment if thetreatment depth has reached or exceeded the threshold.
 8. The method ofdelivering ablative medical treatments to improve biomechanics of claim5, wherein using a laser further comprises using a flash lamp, a highpowered diode, and an optical pump.
 9. A system of ablating biologicaltissue to improve biomechanics comprising: performing an ablatingprocedure on a biological tissue in a pattern while monitoring theablating procedure.
 10. The system of ablating biological tissue toimprove biomechanics of claim 9, wherein the ablating procedure isperformed using a laser.
 11. The system of ablating biological tissue toimprove biomechanics of claim 9, wherein monitoring the ablatingprocedure is performed using OCT (optical coherence tomography).
 12. Thesystem of ablating biological tissue to improve biomechanics of claim11, wherein using OCT further comprises monitoring a depth of ablation.13. The system of ablating biological tissue to improve biomechanics ofclaim 11, wherein the pattern further comprises a golden spiral.
 14. Thesystem of ablating biological tissue to improve biomechanics of claim 9,wherein monitoring the ablating procedure uses feature identificationand positional tracking.
 15. The system of ablating biological tissue toimprove biomechanics of claim 9, wherein the biological tissue isscleral tissue.
 16. The system of ablating biological tissue to improvebiomechanics of claim 9, wherein improving biomechanics includesimproving corneal accommodation.